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Article

Activity and Safety of NAB-FOLFIRI and NAB-FOLFOX as First-Line Treatment for metastatic Pancreatic Cancer (NabucCO Study)

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Medical Oncology Unit, Careggi University Hospital, 50134 Florence, Italy
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Medical Oncology Unit, IRCCS Casa Sollievo della Sofferenza, 71013 San Giovanni Rotondo, Italy
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Medical Oncology Unit, Istituto Nazionale Tumori Regina Elena, 00144 Roma, Italy
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Oncology Unit, Ospedale Santa Maria Nuova—IRCCS, 42100 Reggio Emilia, Italy
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Medical Oncology Unit 2, Azienda Ospedaliero Universitaria Pisana, 56126 Pisa, Italy
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Medical Oncology Unit, Azienda Ospedaliera Universitaria Integrata, 37134 Verona, Italy
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Medical Oncology Unit, ASST Cremona, 26100 Cremona, Italy
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Oncology Unit, Ospedale “Sacro Cuore di Gesù” Fatebenefratelli, 82100 Benevento, Italy
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Clinical Trial Coordinating Center, Careggi University Hospital, 50134 Florence, Italy
*
Author to whom correspondence should be addressed.
On behalf of GOIRC (Italian Cooperative Oncology Group for Clinical Research).
Curr. Oncol. 2021, 28(3), 1761-1772; https://doi.org/10.3390/curroncol28030164
Received: 8 April 2021 / Accepted: 30 April 2021 / Published: 8 May 2021
(This article belongs to the Section Gastrointestinal Oncology)
Background: Relevant improvement in first-line treatment of metastatic pancreatic cancer (mPC) was provided by FOLFIRINOX and by gemcitabine (gem) plus nab-paclitaxel (Nab-p) regimens. Regardless of the first-line treatment survival benefit, most patients survive less than 1 year. Aim: The objectives of this multicenter phase I/II study were to evaluate as first-line chemotherapy (CT) two modified regimens of FOLFIRINOX, replacing either oxaliplatin (Oxa) or irinotecan with Nab-p, in patients with mPC. Methods: The primary objectives of phase 1 were the definition of the dose limit binations, while for phase II they were the characterization of safety and activity of Nab-FOLFIRI and Nab-FOLFOX in mPC. Results: Sixty-three patients received Nab-FOLFIRI or Nab-FOLFOX in phase I. We defined MTD at 120 mg/m2 for Nab-p with FOLFIRI and 160 mg/m2 with FOLFOX. In phase II, we randomized 42 patients for each arm with the following results: (1) overall response rate (ORR) was 31% for both schedules; (2) a clinical benefit rate (CBR) of 69% and 71%; (3) 1-year survival was 41% and 50%; (4) progression free survival (PFS) was 6 months and 5.6 months; (5) median overall survival (OS) was 10.2 and 10.4 months for Nab-FOLFIRI and Nab-FOLFOX, respectively. (6) Neutropenia was the most common grade ≥3 adverse event in our regimens, significantly lower than that reported for the FOLFIRINOX triplet. Conclusion: Nab-FOLFIRI and Nab-FOLFOX might be hopeful first-line CT options for mPC patients, with promising activity and a good safety profile. View Full-Text
Keywords: metastatic pancreatic cancer; nab-paclitaxel; FOLFIRINOX; dose finding metastatic pancreatic cancer; nab-paclitaxel; FOLFIRINOX; dose finding
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MDPI and ACS Style

Giommoni, E.; Maiello, E.; Vaccaro, V.; Rondini, E.; Vivaldi, C.; Tortora, G.; Toppo, L.; Giordano, G.; Latiano, T.P.; Lamperini, C.; Pillozzi, S.; Boni, L.; Antonuzzo, L.; Di Costanzo, F. Activity and Safety of NAB-FOLFIRI and NAB-FOLFOX as First-Line Treatment for metastatic Pancreatic Cancer (NabucCO Study). Curr. Oncol. 2021, 28, 1761-1772. https://doi.org/10.3390/curroncol28030164

AMA Style

Giommoni E, Maiello E, Vaccaro V, Rondini E, Vivaldi C, Tortora G, Toppo L, Giordano G, Latiano TP, Lamperini C, Pillozzi S, Boni L, Antonuzzo L, Di Costanzo F. Activity and Safety of NAB-FOLFIRI and NAB-FOLFOX as First-Line Treatment for metastatic Pancreatic Cancer (NabucCO Study). Current Oncology. 2021; 28(3):1761-1772. https://doi.org/10.3390/curroncol28030164

Chicago/Turabian Style

Giommoni, Elisa, Evaristo Maiello, Vanja Vaccaro, Ermanno Rondini, Caterina Vivaldi, Giampaolo Tortora, Laura Toppo, Guido Giordano, Tiziana P. Latiano, Cinzia Lamperini, Serena Pillozzi, Luca Boni, Lorenzo Antonuzzo, and Francesco Di Costanzo. 2021. "Activity and Safety of NAB-FOLFIRI and NAB-FOLFOX as First-Line Treatment for metastatic Pancreatic Cancer (NabucCO Study)" Current Oncology 28, no. 3: 1761-1772. https://doi.org/10.3390/curroncol28030164

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